title: Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.
abstract: BACKGROUND
  There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response.
  
  
  METHODS
  This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs.
  
  
  CONCLUSIONS
  The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT01825746.
authors.affiliation: Department of Family Medicine and Population Health, Virginia Commonwealth University, PO Box 980251, Richmond, VA 23298-0251, USA. ahkrist@vcu.edu
authors.forename: Alex H
authors.initials: AH
authors.lastname: Krist
authors.forename: Beth A
authors.initials: BA
authors.lastname: Glenn
authors.forename: Russell E
authors.initials: RE
authors.lastname: Glasgow
authors.forename: Bijal A
authors.initials: BA
authors.lastname: Balasubramanian
authors.forename: David A
authors.initials: DA
authors.lastname: Chambers
authors.forename: Maria E
authors.initials: ME
authors.lastname: Fernandez
authors.forename: Suzanne
authors.initials: S
authors.lastname: Heurtin-Roberts
authors.forename: Rodger
authors.initials: R
authors.lastname: Kessler
authors.forename: Marcia G
authors.initials: MG
authors.lastname: Ory
authors.forename: Siobhan M
authors.initials: SM
authors.lastname: Phillips
authors.forename: Debra P
authors.initials: DP
authors.lastname: Ritzwoller
authors.forename: Dylan H
authors.initials: DH
authors.lastname: Roby
authors.forename: Hector P
authors.initials: HP
authors.lastname: Rodriguez
authors.forename: Roy T
authors.initials: RT
authors.lastname: Sabo
authors.forename: Sherri N
authors.initials: SN
authors.lastname: Sheinfeld Gorin
authors.forename: Kurt C
authors.initials: KC
authors.lastname: Stange
mesh_terms: D016000:Cluster Analysis; D003365:Costs and Cost Analysis; D003625:Data Collection; D057286:Electronic Health Records; D005240:Feasibility Studies; D015438:Health Behavior; D006801:Humans; D007400:Interprofessional Relations; D008603:Mental Health; D018802:Patient-Centered Care / Q000191:economics / Q000379:methods*; D064792:Pragmatic Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D011320:Primary Health Care / Q000458:organization & administration*; D057566:Self Report